1. Field
The present invention relates in general to tamperproof packages, and more particularly, to tamperproof packages for encasing articles such as pharmaceutical, food, cosmetic, medical, chemical products and the like, where a change in a package integrity indicating sensor and/or package integrity could evidence a package tampering.
2. Prior Art
Heretofore, all attempts for providing a fail-safe tamperproof package have failed. A number of patents exist which use tamper-proof lids, bottle seals, or other encapsulating members in which an attempt to tamper with the contents will be visible to the consumer. Other existing patents use a sensor to signal loss of package integrity. Although known tamperproof packages do provide varying degrees of protection, they are not fail-safe, and can be circumvented by a determined tamperer by folowing the steps of: placing the entire package into an airtight chamber containing components and/or conditions identical to those existing or used during the original manufacturing process, and/or identical to the sensor used by the package to signal loss of package integrity, so that the changes which signal loss of package integrity will be nullified upon penetrating the package; removing the tamperproofing means; tampering with the contents; and then replacing the tamperproofing means, whereby the package will revert to its original state when returned to normal atmospheric conditions.
A prior art device is unknown to the inventors which provides a fail-safe hermetic multi-barrier tamperproof package for encasing articles such as pharmaceutical, food, cosmetic, medical, chemical products and the like, which incorporates a continuous hermetic cavity defined between at least two nested barrier walls encasing the articles to be protected, which hermetic cavity encloses a sensor comprising a select chemical or material and a select atmosphere such as a substantially evacuated atmosphere to co-operatively comprise a package integrity indicating sensor system, which sensor system is simultaneously reactive to the exterior atmosphere and/or to appropriately separated reagent means incorporated within the package, which reagent means can comprise a select atmosphere such as normal atmosphere air being enclosed within an innermost hermetic barrier such that upon breaching integrity of any package barrier, a chemical or physical response will occur that will produce an indication appealing to the sense of sight, touch, or smell at the point of puncture, or within the cavity that could evicence a package tampering, and; wherein at least one barrier comprises a content-holding hermetic container providing with recloseable closure means, which container is further provided with reagent means enclosed therein.
Examples of existing related patents include U.S. Pat. No. 4,515,679 incorporated herein by reference, disclosing a tamperproof wrap which provides a wrap discoloration, physical change, or deterioration at the point of entry upon wrap puncture. However, the wrap does not provide a hermetic container in a contentholding state being provided with recloseable closure means. A problem with the disclosed wrap is that consumer response toward packages that include liquid layers therein which may ooze upon opening, thereby damaging articles of clothing and the like, can be unfavorable to a certain degree even if the potential for such damage is merely an erroneous perception by the consumer. Another problem with this disclosure is that consumer acceptance of a wrap as disclosed therein can be limited, since the consumer tends to mistrust ingestible products which are package in a manner such that they are conceived to be easily contaminable by the chemicals contained therein, even if the chemicals are stated to be substantially harmless, unless he or she has special knowledge of the particular chemical used.
U.S. Pat. No. 4,098,577, incorporated herein by reference, discloses a method for detecting the loss of integrity of a sealed package, which method uses a sensor to signal loss of package integrity. This disclosure also does not provide a hermetic container in a content-holding state being provided with recloseable closure means. This disclosure has a further limitation in that the chemical comprising the sensor is in direct contact with the articles enclosed therein, thereby increasing the negative response by the consumer toward the contents.
The present invention provides a separate hermetic container adapted with recloseable closure means for the articles to be protected, thereby eliminating the negative responses by the consumer encountered by the referenced disclosures.
The primary object of the referenced patents can be circumvented by a determined and sophisticated tamperer by use of the previously described tampering process.
In recent times, the deaths of a number of victims of random illegal tampering with packages containing capsules of pain relief medicine have created great anxiety in the consuming public toward packaged products. The threat to the general public health has more recently become widespread by a wave of indiscriminate tampering with packages containing a variety of products including: cartons containing a popular gelatin desert, bottles containing baby foods, and bottles containing soft drinks.
Therefore, the need for a new class of packaging providing a fail-safe tamperproof package in which any puncture will produce a readily apparent indication that could evidence a package tampering remains urgent.
Therefore, it is an object of the present invention to provide a tamperproof package which is fail-safe.
It is another object of the present invention to provide a fail-safe tamperproof package for encasing articles subject to tampering where a change in a package integrity indicating sensor and/or package integrity could indicate a package tampering.
It is another object of the present invention to provide a fail-safe tamperproof package for encasing articles subject to tampering where breaching package integrity will provide an indication appealing to the sense of sight, touch, or smell at the point of puncture, or within the package that could evidence a package tampering.
It is still another object of the present invention to provide a fail-safe tamperproof package that can be easily constructed in multiple nested barriers which package includes a package integrity indicating sensor which is simultaneously reactive to the exterior atmosphere and/or to appropriatley separated reagent means provided within the package so that breaching integrity of any barrierwill result in a chemical or physical response that will produce an indication appealing to the sense of sight, touch, or smell at the point of puncture, or within the package that could evidence a package tampering.
It is another object of the present invention to provide a fail-safe tamperproof package that will provide prevention of oxidation or contamination of articles enclosed therein.
It is another object of the present invention to provide a fail-safe tamperproof package that will improve shipping, handling, and storing of articles enclosed therein.
It is still another object of the present inventin to provide a fail-safe tamperproof package that will improve shipping, handling, storing, applying, and dispensing of drugs and medications enclosed therein.
It is another object of the present invention to provide a fail-safe tamperproof package that will maintain purity of materials or substances enclosed therein.
It is another object of the present invention to provide a fail-safe tamperproof package that can control or regulate temperature of articles enclosed therein.
It is another object of the present invention to provide a fail-safe tamperproof package that can enhance freshness and/or shelf life of articles enclosed therein.
It is still another object of the present invention to provide a fail-safe tamperproof package where the articles to be protected from tampering are completely enclosed about their periphery by a hermetically-sealed sensor which sensor is sandwiched between inwardly and outwardly disposed reagent means so that placing the entire package into an airtight chamber incorporating components and/or conditions identical to those wxisting or used during the original manufacturing process, and/or identical to the sensor enclosed therein in an attempt to tamper with the contents will be futile, since the duplicate conditions into which the entire package is placed and/or the identical components contained in the airtight chamber into which the package is placed may circumvent the peripherally disposed sensor of the package, but will be reactive to the inwardly disposed reagent means incorporated within the package when mixing with one another upon breaching package integrity.
It is still another object of the present invention to provide a fail-safe tamperproof package in which the components comprising the construction of the packages are made of a non-toxic digestible material, which components include a plastic coating made of a novel material similar to styrofoam which is waterproof and substantially impermeable to stomach acid and to digestive enzymes, which material is digestible to bacteria present in the large intesting, and which material is formed and constructed to comprise articles such as capsules of medicine or other human ingestible products.